Hepatic SteatosisHSACNCT02493153
Hepatic Steatosis After Cholecystectomy
An observational study of Hepatic Steatosis, run by Sangchul Yun.
Trial summary
The investigators are very pleased to register the study entitled "A prospective study for the effect of cholecystectomy to the liver in consideration of hepatic steatosis 3months after cholecystectomy with Ultrasound". Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Steatosis
- What is being tested?
- Laparoscopic Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: From Oct, 2013 to Jul, 2014, a cohort of 82 consecutive patients with cholecystectomy was prospectively collected and followed-up.
Who may be able to join
- From Oct, 2013 to Jul, 2014, patients with a presumptive diagnosis of cholelithiasis and gallbladder polyps who was cholecystectomized
Who cannot join
- inflammatory diseases; anemia; hemochromatosis; Wilson disease; autoimmune hepa-titis; primary biliary cirrhosis; sclerosing cholangitis; biliary obstruction; alpha-1 antitrypsin deficiency; ischemic cardiac or cerebrovascular disease; impaired renal function; malignan¬cies; use of estrogens, amiodarone, steroids, tamoxifen, or lipid-lowering agents; viral hepatitis (positive serum hepatitis B surface antigen and positive serum hepatitis C antibody); iron overload (transferrin saturation ≥50%); and pregnancy.
About this study
Official title: A Prospective Study for the Effect of Cholecystectomy to the Liver in Consideration of Hepatic Steatosis 3months After Cholecystectomy With Ultrasound
The investigators are very pleased to register the study entitled "A prospective study for the effect of cholecystectomy to the liver in consideration of hepatic steatosis 3months after cholecystectomy with Ultrasound".
This study deals with prospective ultrasound study about hepatic steatosis development 3 months after cholecystectomy. This study was approved by the Institutional Review Board of the local institute. From Oct, 2013 to Jul, 2014, assessment of liver changes after cholecystectomy was carried out in 82 patients with gallbladder disease. In conclusion, the investigators thought that cholecystectomy might be considered as a risk factor for hepatic steatosis.
Read the detailed description
All subjects underwent a complete medical history and physi¬cal examination. Physical examination included measurements of height and weight. Subjects with a body mass index (BMI) ≥ 30 kg/m2 were considered obese. Laboratory tests included white blood cell (WBC) count, serum albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, amylase, lipase, total cholesterol, triglycerides (TG), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), and high-sensitivity C-reactive protein (hsCRP).
In order to analyze the presence and severity of hepatic steatosis, hepatic steatosis index (HSI), US and liver biopsy was used. The hepatic steatosis index (HSI) was calculated as 8 × ALT/AST + BMI +2 (if diabetes) +2 (if female gender). All patients underwent US at the time of operation and 3 months postoperatively. All US procedures were performed by one board-certified radiologist who did not have information about the patients. Procedures were done using an iU22 apparatus (Philips Ultrasound, Bothell, WA, USA) or an EUB-7500 apparatus (Hitachi, Tokyo, Japan) equipped with a 5 MHz convex transducer. For evaluation of fatty liver, the severity of liver echogenicity was categorized. Normal echogenicity was a mild and slightly diffuse increase in hepatic echogenicity with normal visualization of diaphragm and intrahepatic vessels. Moderate echogenicity was a moderately diffuse increase in hepatic echogenicity with slightly impaired visualization of diaphragm and intrahepatic vessels. Severe echogenicity was a marked increase in hepatic echogenicity with poor or nonvisualization of the intrahepatic vessel borders, diaphragm, and posterior segment of the right hepatic lobe.
Each US image was reread by the same radiologist who was blinded to the initial reading 1 month after the initial assessment to assess intraobserver variability. Liver biopsy was performed during cholecystectomy using liver wedge resection in 10 patients who had provided informed consent preoperatively. All specimens were reviewed by two pathologists with single blinded method. Sections were stained with hematoxylin and eosin (H\&E) and examined at X40 magnification. Steatosis was divided into four stages using the Brunt criteria.
- Conditions
- Hepatic Steatosis
- Being tested
- Laparoscopic Cholecystectomy
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic CholecystectomyProcedure or surgery
Laparoscopic cholecystectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound finding of hepatic steatosis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startOct 2013
- Primary completionJul 2015
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatic SteatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sangchul Yun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sangchul Yun, Soonchunhyang University Hospital
- Investigators
- Dongho Choi, Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493153
- Sponsor's protocol ID
- HY-2013-N
- Acronym
- HSAC
- Status last verified
- Nov 2015
- First submitted
- 6 Jul 2015
- Last updated
- 23 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ruhl CE, Everhart JE. Relationship of non-alcoholic fatty liver disease with cholecystectomy in the US population. Am J Gastroenterol. 2013 Jun;108(6):952-8. doi: 10.1038/ajg.2013.70. Epub 2013 Apr 2.
PubMed 23545713Yun S, Choi D, Lee KG, Kim HJ, Kang BK, Kim H, Paik SS. Cholecystectomy Causes Ultrasound Evidence of Increased Hepatic Steatosis. World J Surg. 2016 Jun;40(6):1412-21. doi: 10.1007/s00268-015-3396-7.
PubMed 26796885
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study for the Effect of Cholecystectomy to the Liver in Consideration of Hepatic Steatosis 3months After Cholecystectomy With Ultrasound
- ClinicalTrials.gov ID
- NCT02493153
- Acronym / sponsor ID
- HSAC / HY-2013-N
- Conditions
- Hepatic Steatosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Sangchul YunUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2016 (estimated)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are very pleased to register the study entitled "A prospective study for the effect of cholecystectomy to the liver in consideration of hepatic steatosis 3months after cholecystectomy with Ultrasound".
This study deals with prospective ultrasound study about hepatic steatosis development 3 months after cholecystectomy. This study was approved by the Institutional Review Board of the local institute. From Oct, 2013 to Jul, 2014, assessment of liver changes after cholecystectomy was carried out in 82 patients with gallbladder disease. In conclusion, the investigators thought that cholecystectomy might be considered as a risk factor for hepatic steatosis.
Detailed description
All subjects underwent a complete medical history and physi¬cal examination. Physical examination included measurements of height and weight. Subjects with a body mass index (BMI) ≥ 30 kg/m2 were considered obese. Laboratory tests included white blood cell (WBC) count, serum albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, amylase, lipase, total cholesterol, triglycerides (TG), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), and high-sensitivity C-reactive protein (hsCRP).
In order to analyze the presence and severity of hepatic steatosis, hepatic steatosis index (HSI), US and liver biopsy was used. The hepatic steatosis index (HSI) was calculated as 8 × ALT/AST + BMI +2 (if diabetes) +2 (if female gender). All patients underwent US at the time of operation and 3 months postoperatively. All US procedures were performed by one board-certified radiologist who did not have information about the patients. Procedures were done using an iU22 apparatus (Philips Ultrasound, Bothell, WA, USA) or an EUB-7500 apparatus (Hitachi, Tokyo, Japan) equipped with a 5 MHz convex transducer. For evaluation of fatty liver, the severity of liver echogenicity was categorized. Normal echogenicity was a mild and slightly diffuse increase in hepatic echogenicity with normal visualization of diaphragm and intrahepatic vessels. Moderate echogenicity was a moderately diffuse increase in hepatic echogenicity with slightly impaired visualization of diaphragm and intrahepatic vessels. Severe echogenicity was a marked increase in hepatic echogenicity with poor or nonvisualization of the intrahepatic vessel borders, diaphragm, and posterior segment of the right hepatic lobe.
Each US image was reread by the same radiologist who was blinded to the initial reading 1 month after the initial assessment to assess intraobserver variability. Liver biopsy was performed during cholecystectomy using liver wedge resection in 10 patients who had provided informed consent preoperatively. All specimens were reviewed by two pathologists with single blinded method. Sections were stained with hematoxylin and eosin (H\&E) and examined at X40 magnification. Steatosis was divided into four stages using the Brunt criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- From Oct, 2013 to Jul, 2014, a cohort of 82 consecutive patients with cholecystectomy was prospectively collected and followed-up.
Key inclusion criteria (1 listed)
- From Oct, 2013 to Jul, 2014, patients with a presumptive diagnosis of cholelithiasis and gallbladder polyps who was cholecystectomized
Key exclusion criteria (1 listed)
- inflammatory diseases; anemia; hemochromatosis; Wilson disease; autoimmune hepa-titis; primary biliary cirrhosis; sclerosing cholangitis; biliary obstruction; alpha-1 antitrypsin deficiency; ischemic cardiac or cerebrovascular disease; impaired renal function; malignan¬cies; use of estrogens, amiodarone, steroids, tamoxifen, or lipid-lowering agents; viral hepatitis (positive serum hepatitis B surface antigen and positive serum hepatitis C antibody); iron overload (transferrin saturation ≥50%); and pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic CholecystectomyLaparoscopic cholecystectomy | Procedure or surgery | – |
Primary outcome
Ultrasound finding of hepatic steatosis
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2015.
- Results publication: PubMed 23545713Ruhl CE, Everhart JE. Relationship of non-alcoholic fatty liver disease with cholecystectomy in the US population. Am J Gastroenterol. 2013 Jun;108(6):952-8. doi: 10.1038/ajg.2013.70. Epub 2013 Apr 2.
- Derived from this study: PubMed 26796885Yun S, Choi D, Lee KG, Kim HJ, Kang BK, Kim H, Paik SS. Cholecystectomy Causes Ultrasound Evidence of Increased Hepatic Steatosis. World J Surg. 2016 Jun;40(6):1412-21. doi: 10.1007/s00268-015-3396-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongho Choi principal investigator
Hanyang University
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Steatosis, run by Sangchul Yun.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound finding of hepatic steatosis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02493153, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2015.